Unbanned: These Peptides Could Be Greenlit By The FDA Soon

Peptides are strings of amino acids that serve a wide range of functions in the human body. They've also been synthesized to make medications, such as insulin and GLP-1, a peptide used for weight management. Now, new synthetic peptides are all the rage among the "Make America Healthy Again" movement, a U.S. Department of Health initiative led by Health Secretary Robert F. Kennedy Jr. Although most synthetic peptides haven't been extensively proven to be effective or safe, advocates have pressured the FDA to greenlight the supplements for use in anti-aging treatments, body building, and injury recovery. And the most vocal advocate for peptides is RFK Jr. himself.

Health Secretary RFK Jr. has publicly stated that he's a "big fan of peptides" (via The Hill). He and other peptide fans want to bring the supplement out of the fringe and into the mainstream. In response, the Food and Drug Administration (FDA) plans to convene an advisory panel in July to decide whether or not to allow synthetic peptides to be manufactured and sold by pharmacies. The biggest obstacle is a lack of research surrounding the health risks and benefits. Ironically, RFK's administration also claims to want to "restore public trust" in vaccines by relying on "credible, reliable, and impartial scientific evidence" (via the U.S. Department of Health and Human Services). The standards are inconsistent, to say the least.

Certainly, some synthetic peptides have promise. For instance, AOD-9604 is a synthetic peptide meant to help with fat loss by boosting metabolism. Limited data suggests that AOD-9604 can help with weight loss to a modest degree. Then, there are more controversial peptides . BPC-157 is a trendy (and potentially concerning) peptide that many fitness influencers believe can heal tissues faster, improve gut health, and reduce inflammation. But questions remain. Most clinical research data about BPC-157 is extremely limited, and most experimental studies used rodent test subjects.

The bold claims of peptide advocates

Perhaps the most common claim about synthetic peptides is that they can help with weight loss. Currently, there are two weight-loss peptides approved by the FDA: tirzepatide and semaglutide (commonly sold as Ozempic, which isn't entirely risk-free, either, sometimes causing muscle loss that's yet to be fully explained). But scientists aren't sure about the risks of other weight-loss peptides, especially how they interact with other medications. In fact, the FDA has found that combining (or "compounding") tirzepatide and Ozempic may result in adverse reactions, recording over 775 cases, leaving questions about non-approved alternatives. Many non-approved synthetic peptides are labeled "not for human consumption."

Advocates argue that with FDA regulation of synthetic peptides, greater quality control and oversight can be used in their production. But safety isn't just a question of regulating production. Most of the peptides awaiting approval lack rigorous human trials, and any promising results publicized by peptide advocates are typically from animal studies. AOD-9604, for instance, is claimed to aid in fat loss, yet the FDA has not approved it due to a lack of long-term human trials. Many people have reported side effects from taking AOD-9604, including headaches, nausea, and fatigue. Does this mean AOD-9604 is dangerous? Not necessarily, but more data would be welcome.

Other peptides up for review include TB-500, purported to promote injury healing, and Emideltide, also known as the "Delta Sleep-Inducing Peptide" (DSIP). Then, there's KPV, intended for reducing inflammation, and MOTs-C, said to promote health and energy. There are others, too, but they all come with essentially the same alleged properties: Synthetic peptides are claimed to offer metabolic, inflammatory, and energy benefits. For now, the only evidence for those benefits largely comes from testimony among social media influencers and non-experts. In July, we'll see if the FDA decides that testimony isn't enough.

Recommended